Transcatheter Stent-Valves and Methods, Systems and Devices for Addressing Para-Valve Leakage

ABSTRACT

Some embodiments of the present disclosure provide a stent-valve for transcatheter implantation to replace a cardiac valve. In some embodiments, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation. In some embodiments, the stent-valve comprises a stent, a plurality of leaflets for defining a prosthetic valve, an inner skirt, an outer skirt, and a paravalve seal for sealing against surrounding tissue. In some embodiments, the paravalve seal comprising material that swells in response to contact with blood or components thereof.

RELATED APPLICATIONS

The present disclosure claims priority to European patent applicationno. EP 12 002 015.1 filed, Mar. 22, 2012, the entire disclosure of whichis herein incorporated by reference.

FIELD OF THE DISCLOSURE

The present disclosure relates to the field of transcatheterstem-valves. In some embodiments, the stent-valve may be a cardiacvalve, for example, an aortic valve.

BACKGROUND

Transcatheter valve implantation (for example, transcatheter aorticvalve implantation (TAVI)) is an evolving technology for replacementvalve therapy that (i) avoids the trauma of conventional open-chestsurgery, and (ii) avoids the need for heart and lung bypass. In such atechnique, a stent-valve is compressed and loaded into a deliverycatheter. The delivery catheter is introduced to the desired site ofimplantation (for example at the heart) via a percutaneous route or viaminimally invasive surgery. The stent-valve is deployed into theimplantation position from or by the delivery catheter, and the deliverycatheter is then withdrawn.

Despite the successes of transcatheter stent-valves, technologicalchallenges remain. One such challenge is preventing leakage of bloodaround the stent-valve (so called para-valve leakage). The above stentsform a friction fit with the native anatomy to anchor the stent-valve inposition, and are round in cross-section. However, the native anatomy inwhich the stent is implanted is often off-round and is different foreach person. Moreover, heavy calcification of the native anatomy mayobstruct full depolyment of any stent, and make the native anatomy evenmore irregular. It can sometimes be difficult to provide a perfectlysealing fit between the stent-valve and the surrounding anatomy.

In order to address para-valve leakage, it is known to incorporate anexternal skirt or cover as part of the stent-valve. For example, theskirt is made of compressible biocompatible material, such aspericardial tissue or PET. The thicker the material of the skirt, themore able the skirt is to occlude gaps and effect a seal. However, adisadvantage is that such skirts add to the bulk of the stent-valve. Athick skirt makes the stent-valve problematic to compress to a desirablysmall size for implantation.

It would be desirable to provide a technique for mitigating para-valveleakage without substantially hindering the compressibility of astent-valve.

SUMMARY OF THE DISCLOSURE

In some embodiments of the present disclosure, a stent-valve fortranscatheter delivery is provided, with the stent-valve comprising astent supporting a plurality of valve leaflets.

In some embodiments, a seal for mitigating para-valve leakage (which maybe referred herein throughout either as “seal” or “para-valve leakageseal”) is provided. The seal may be of flexible and/or compliantmaterial.

In some embodiments, the seal is carried by at least one seal support.The seal support may be collapsible to a stowed condition in which theseal is relatively streamlined or compressed with respect to the stentwhen the stent is compressed. For example, in the stowed condition, theseal support may be generally coplanar with the body of the stent, ormay be arranged compressed against the stent. The seal support may bedeployable to a deployed condition in which the support holds or biasesthe seal to a deployed state with respect to the stent. The seal supportmay be self-deploying from the stowed condition to the deployedcondition. For example, the seal support may be constrainable in thestowed condition by sheathing of the stent in a compressed state fordelivery. The seal support may be self-deploying from the stored statewhen the effect of the constraining sheath is removed. The seal supportmay be of shape memory material, for example, nitinol.

Various forms and structure of seal support are envisaged. In someembodiments, the seal support may be integral with the stent (e.g.integrally formed as part of the stent). In other forms, the sealsupport may be distinct from the stent. Such a seal support mayoptionally be coupled to or captive on the stent.

The seal support may be configured to bear against the material of theseal without penetrating through the seal material. For example, theseal support may have a shape that distributes contact force. A functionof the seal support may be to urge the seal outwardly without the sealsupport penetrating through the seal material or into a tissue surfaceagainst which the seal is desired.

In some embodiments, the seal support may comprise a biasing elementthat biases the seal to a deployed condition (for example). The sealsupport (e.g. biasing element) may comprise, for example, a cantileverelement (or a plurality of cantilever elements). The cantilever elementsmay be capable of flexing independently of one another, in order toprovide a high degree of local seal conformity against an irregularlumen or tissue surface. In some embodiments, each cantilever element isassociated with a respective aperture of a lattice structure of thestent. The cantilever elements may, for example, have one end coupled(or integral) with the stent body, and an opposite or remote end that isfree to deploy outwardly. The remote end may have a rounded or enlargedor pad tip to avoid having a sharp end that might otherwise riskpenetrating through the seal material. The cantilever elements mayextend generally in the same direction as each other (e.g. having theremote end directed to one end (such as the outflow end) of thestent-valve), or the cantilever elements may be arranged in two oppositedirections (e.g. at least one pointing towards the outflow end, and atleast another pointing towards the inflow end), or the cantileverelements may be arranged in a variety of different directions.

In some embodiments, the seal support comprises a ring shape, or tubularshape, or annular member. The member may have an annular coil shape.

In some embodiments, the seal support comprises a member that can bestowed in a generally elongate or helical form, and which deploys to aradially expanded loop form.

In some embodiments, the seal support comprises a portion of the stentthat everts from a stowed condition to a deployed condition. Eversion ofthe stent can provide radial expansion upon deployment withoutincreasing significantly the diameter of the stent when compressed(de-everted). For example, an inflow end or portion of the stent mayevert towards the outflow end.

In some embodiments, the stent carries a sealing skirt (or web). Theseal support may bias the skirt (or portions thereof) radially outwardlyto distend away from the body of the stent.

Additionally or alternatively to embodiments noted above for a sealsupport, a seal of the stent-valve may be configured to be responsive todirection of blood flow past the seal, relative to inflow and outflowends of the stent-valve. The seal may be configured such that blood flowin a reverse direction (for outflow to inflow) biases the seal to adeployed state to obstruct such flow.

For example, in some embodiments, the seal may comprise at least one webdefining one or more pockets. The one or more pockets may be configuredto fill with blood (or blood components) in response to blood flow inthe reverse direction, such that the pocket distends outwardly.Distention of the pocket can fill a gap between the stent-valve and thesurrounding anatomy, to obstruct the reverse flow of blood past thepocket.

In some embodiments, the pocket may be defined or carried at arespective aperture of a lattice structure of the stent. The pocket maybe defined at least partly by an outer skirt carried on an exterior ofthe stent. Additionally or alternatively, the pocket may be defined atleast partly by an inner skirt carried on an interior of the stent.

Additionally or alternatively to the above embodiments, a seal maycomprise a skirt at least a portion of which is captive with respect tothe stent, and at least a further portion of which is free to deploy orfloat relative to the stent.

In some embodiments, the further portion may contact a surroundingtissue or lumen wall before the body of the stent is fully deployed. Aspart of the deployment procedure, the stent may be displaced or biasedin a first axial direction to seat against native leaflets. Thefrictional contact of the skirt against the tissue may cause the furtherportion of the skirt to bunch or wrinkle in the axial direction duringthe displacement action. Such bunching or wrinkling may provideadditional material to fill voids or gaps between the stent and thesurrounding tissue.

Additionally or alternatively, in some embodiments, the further portionof the skirt may seal may be responsive to direction or paravalve bloodflow or to pressure blood. The further portion may, for example, deployoutwardly to contact a surrounding tissue lumen wall. The furtherportion may form a generally channel shape in response to pressure ofblood or flow of blood in the reverse direction. The channel shape maybias an outer portion of the skirt to seat against the surroundingtissue or lumen surface.

Additionally or alternatively to the above embodiments, a seal of thestent-valve may be embossed to present a non-smooth surface. Forexample, the embossing may be defined by one or more sutures. The one ormore sutures may define a zig-zag pattern. The suture may define agenerally continuous embossment to obstruct blood flow past the stent.

Additionally or alternatively to the above embodiments, a seal of thestent-valve may be generally oversized compared to the diameter of thestent. The seal may be bunched or pleated by connections (e.g. suturing)to the stent that causes bunching or pleating between the connections.The bunching/pleating may create additional compliant bulk of sealmaterial able to fill voids or gaps between the stent-valve and thesurrounding tissue or lumen surface. The positions of the connectionsmay define bunching or pleating in directions in a pattern thatobstructs leakage of blood.

Additionally or alternatively to the above embodiments, a seal of thestent-valve may be configured to be self-expanding or self-filling dueto a physical property of the seal.

For example, in some embodiments, the seal may be of or comprise a foam,sponge or fibrous material. Such a material may self-expand resilientlywhen the stent deploys. Additionally or alternatively, such a materialmay absorb blood (and/or components thereof) within its pores orinterstices in order to expand the material physically or add bulk.

In some embodiments, the seal may be generally flat and/or tubular in astowed state, and may roll or curl into an annular bead or doughnut whenin a deployed state. The seal may be self-biased to the deployed state,but be resiliently deformable to the stowed state during compression ofthe stent for loading into a delivery apparatus. Upon removal of aconstraining effect of a sheath of the delivery apparatus, the seal maybe configured to readopt the deployed state, in order to provide aradially enlarged seal around the stent.

in some embodiments, at least a portion of the stent comprises a latticestructure, and the stent-valve further comprises one or more sealsdeployable from or through apertures of the lattice. In one form, theseals comprise web portions of material that define pockets associatedwith respective apertures of the lattice. The web portions may beconfigured to distend outwardly from the respective apertures. Forexample, in some embodiments, the web portions define pockets open on orto one side such that a respective pocket fills with blood to distendoutwardly from the aperture of the lattice. Additionally oralternatively, the lattice structure of the stent may comprise biasingelements for biasing the web portions (e.g. pockets) of materialradially outwardly from the lattice structure.

In some embodiments, the stent carries a sealing skirt (or web). Thestent may comprise biasing elements for biasing the skirt (or portionsthereof) radially outwardly to distend away from the body of the stent.The sealing skirt may optionally be carried on the exterior of thestent. An inner skirt (or web) may optionally be carried on the interiorof the stem (and optionally coupled directly to the leaflets). At leastone of the skirts may be of fabric (e.g. PET). Additionally oralternatively, at least one of the skirts may be of biological tissue,for example, pericardium.

In some embodiments, a biasing element distinct from the stent may biasa seal outwardly. For example, the biasing element may be a ring element(e.g. closed ring or split ring), within an annular seal. The biasingelement may be compressible with the stent to a radially compressedcondition. The biasing element may expand (e.g. self-expand) towards aradially expanded state when the stent is deployed. The biasing elementmay be of shape memory material, e.g. nitinol.

Certain features, ideas and advantages of the embodiments taught by thepresent disclosure are identified above and/or in the appended claims,but these do not limit any embodiment or invention disclosed herein.Protection is claimed for any novel idea or feature described hereinand/or illustrated in the drawings whether to not emphasis has beenplaced thereon.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting embodiments of the disclosure are illustrated in theaccompanying drawings, in which:

FIG. 1 is a schematic drawing illustrating a stent-valve 10, accordingto some embodiments of the disclosure.

FIG. 2a is a front view of a seal arrangement with cantilevered sealsupports, and FIG. 2b is a side view of FIG. 2a in a deployedconfiguration, each according to some embodiments of the disclosure.

FIG. 3 is a schematic view of a seal arrangement with an annular wireseal support according to some embodiments of the disclosure.

FIG. 4a is a schematic perspective view of an elongate seal supportaround the stent in a compressed state, and FIG. 4b is a schematic topview of the seal when in a deployed state, each according to someembodiments of the disclosure.

FIG. 5a is a schematic view of a seal arrangement in a sheathednon-everted state, FIG. 5b shows initial unsheathing of the sealarrangement of FIG. 5a to permit everting, and FIG. 5c shows the sealarrangement of FIG. 5a when unsheathed, each according to someembodiments of the disclosure.

FIG. 6 is a schematic side view of a further example of seal arrangementwith flexible cantilever arms, according to some embodiments of thedisclosure.

FIG. 7a is a schematic side view of a seal arrangement comprising arollable cuff when in a deployed state, and FIG. 7b is a schematic viewof the seal arrangement when in a stowed, sheathed state, each accordingto some embodiments of the disclosure.

FIG. 8 is a schematic side view of a seal arrangement comprising aporous material, according to some embodiments of the disclosure.

FIG. 9a is a schematic side view of a seal arrangement comprising afloating skirt, and FIG. 9b is a schematic side view of the effect ofthe seal arrangement of FIG. 9a when implanted, according to someembodiments of the disclosure.

FIG. 10 is a schematic illustration of an alternative arrangement of afloating skirt seal, according to some embodiments of the disclosure.

FIG. 11 is a schematic illustration of an alternative seal arrangementusing a plated skirt, according to some embodiments of the disclosure.

FIG. 12 is a schematic illustration of an alternative seal arrangementusing a folded skirt, according to some embodiments of the disclosure.

FIG. 13 is a schematic illustration of an alternative seal arrangementusing distensible pockets, according to some embodiments of thedisclosure.

FIG. 14 is a schematic drawing of an alternative sealing arrangementusing swellable material, according to some embodiments of thedisclosure.

FIG. 15 is a schematic drawing illustrating administration of a sealantaround the stent-valve, according to some embodiments of the disclosure.

FIG. 16 is a schematic view of an alternative sealing arrangement usingcoagulation material, according to some embodiments of the disclosure.

FIG. 17 is a schematic view of an alternative sealing arrangement usingmaterial that elutes calcium locally, according to some embodiments ofthe disclosure.

FIG. 18 is a partial schematic view of optional details of a stent-valveof FIG. 1, according to some embodiments of the disclosure.

FIG. 19 is a schematic section of the paravalve seal of FIG. 18,according to some embodiments of the disclosure.

DETAILED DESCRIPTION

Referring to FIG. 1 (and FIG. 18), a cardiac stent-valve 10 isillustrated for transcatheter implantation. The stent-valve 10 may becardiac stent-valve, for example, an aortic stent-valve, a mitralstent-valve, a pulmonary stent-valve or a tricuspid stent-valve, forimplantation at the respective valve position in a human heart.

The stent-valve 10 may optionally comprise biological tissue (forexample, pericardium (such as porcine pericardium and/or bovinepericardium) and/or natural cardiac valve leaflets (for example, naturalporcine cardiac valve leaflets, optionally attached to a portion ofnatural cardiac wall tissue). The biological tissue may be fixed, forexample, using glutaraldehyde.

The stent-valve 10 may be compressible to a radially compressedcondition (not shown) for delivery using a delivery catheter, and beexpandable to an expanded condition (as shown) at implantation. Thestent-valve 10 may comprise a stem 12 carrying a plurality of leafletsdefining a valve 14. Various geometries of stent 12 may be used in someembodiments, the stent 12 may include one of more of: a lower tubular orcrown portion 16; an upper crown portion 18; a plurality of upstandingcommissural supports 20; and a plurality of stabilization arches 22. Inuse, the lower portion 16 of the stent 12 may be configured to bedeployed after the other regions of the stent 12 have first been atleast partly deployed. For example, the arches 22, the supports 20 andthe upper crown 18 may be deployed at least partly before the lowerportion 16 (in that order, or in reverse order, or in a differentorder). At least once the upper crown 18 has been at least partlydeployed, the stent 12 may be urged and/or displaced in the direction ofarrow 24 to seat the upper crown 18 against native leaflets at theimplantation site. Deploying the lower portion 16 last fixes the stent12 in its final position.

At least the lower portion 16, and optionally a portion of the uppercrown 18, may be formed by a lattice structure of the stent. The latticestructure may define apertures, for example, generally diamond-shapedapertures.

The native leaflets may generally overlap a portion 26 of the stent. Thenative valve annulus may overlap a portion 28 of the stent.

Optionally, the stem-valve 10 may further comprise an inner skirt 30communicating with the leaflets 14 and carried on an interior of thestent 12. Additionally or alternatively, the stent-valve 10 may furthercomprise an outer skirt 32 carried on an exterior of the stent 12. Whenboth skirts are provided, the skirts may partially overlap. The skirtsmay be offset such that one skirt (e.g. the outer skirt 32) extendsfurther towards a lower extremity of the stent 12 than the other (e.g.inner skirt 30). Additionally or alternatively, one skirt (e.g. theinner skirt 30) extends further towards an upper extremity of the stent12 than the other (e.g. outer skirt 32). The skirts may be of anysuitable flexible and/or compliant material, for example, fabric (e.g.of PET), or of plastics film (e.g. of PET), or of biological tissue(e.g. of pericardium).

Optionally, at least the outer skirt 32 is positioned to leave the uppercrown 18 substantially un-obscured by the outer skirt 32. Such anarrangement may assist good blood flow to the coronary arteries (forexample, in the case of a stent-valve for the aortic valve).

In some embodiments, the lower portion 16 has an extremity formed with asubstantially zig-zag shape. The zig-zag shape may comprise lower apexes16 a and upper apexes 16 b. The upper apexes 16 b may be masked in FIG.1 by the superimposed presentation of both the front most and rearmostcells of the lattice structure. The zig-zag shape may be substantiallycontinuous around the circumference of the stent 12. The outer skirt 32may have a peripheral edge having a zig-zag shape that matchessubstantially the zig-zag shape of the extremity of the lower portion16. Such an arrangement can avoid excessive material at the extremity,and thereby facilitate crimping of the stent-valve 10. At the same time,the outer skirt 32 covers (for example, complete) open cells of thelattice structure down to the stent extremity to reduce risk of bloodleakage through the apertures of the cells. The outer skirt 32 can alsoprovide a layer of material over the struts of the stent, thereby tocushion the engagement between the stent and the sensitive native hearttissue.

The valve 14 may comprise biological tissue, for example, pericardium(such as porcine pericardium or bovine pericardium) or natural cardiacvalve leaflets (for example, natural porcine cardiac valve leaflets,optionally attached to a portion of natural cardiac wall tissue). Otherbiological or non-biological material could also be used for the valve14, as desired.

The stent 12 may optionally be of a self-expanding type that iscompressible to the compressed state for loading into a deliverycatheter having a sheath for constraining the stent 12 in the compressedstate for delivery to the site of implantation. In use, by removal ofthe constraining effect of the sheath, the stent 12 self-expands to ortowards the expanded state. A self-expanding stent may, for example, meof shape-memory material, for example, shape-memory metal alloy, forexample, nitinol. Alternatively, the stent 12 may be configured to beexpanded by application of an expanding force from the deliverycatheter, such as by using an expansion balloon.

There now follows a description of various seal configurations that maybe used with the above-described stent-valve 10. The seal configurationsmay also be used with different stent shapes and configurations.

FIG. 2 illustrates a first example of seal support in the form of aplurality cantilever elements 40 mounted on or integral with the stent12. Each cantilever element 40 may be associated with a respectiveaperture 42 of the lattice structure. Each cantilever element 40 may bebendable generally independently of the others. Each cantilever element40 may be movable between a stowed condition, in which the cantileverelement is generally co-planar with the portion of the stent 12 aroundthe aperture 42 (or at least is compressed to lie directly or indirectlythere against), and a deployed condition in which the cantilever element40 is biased radially outwardly from the body (e.g. lower portion 16) ofthe stent 12 (FIG. 2b ). The seal support urges a seal (e.g. the outerskirt 32) outwardly so as to fill gaps or voids between the stent-valve10 and the surrounding lumen/tissue. The ability of the cantileverelements 40 to flex independently can provide a high degree of localconformity. Each cantilever element 40 may have a remote end 40a in theform of a rounded, or pad-like, or other non-damaging shape that canbear against the seal material to bias the seal radially outwardly,without penetrating through, or puncturing, the seal material.

The cantilever elements 40 may be arranged generally in the sameorientation (e.g. with the remote ends 40 a directed towards one end,e.g. the outlet end, of the stent 12), or distributed to be orientatedin two opposite directions, or be distributed to be orientated in avariety of different directions.

The seal urged by the cantilever elements 40 may be generallycontinuous, or it may be discontinuous in the form of webs or pockets.The pockets may be arranged such that back-pressure of blood, orpara-valvular blood flow in the reverse direction from outlet to inletend of the stent 12, fills the pockets to cause the pockets further todistend, thereby enhancing the seal effect to obstruct suchpara-valvular flow. Further detail of such pockets is also describedwith reference to FIG. 13, and any of such features may also be usedwith the present example.

Referring to FIG. 3, a seal support 46 is illustrated in the form of anannular wire or ring that is oversize compared to the stent 10. Theannular wire is compressible to a stowed state when the stent iscompressed, and expands to a deployed state when unconstrained, to urgethe seal 48 to a radially expanded state to form a seal against thesurrounding tissue/lumen.

Referring to FIG. 4, a seal support 50 is illustrated in the form of anelongate member carrying a seal 52. The seal support is compressible toa stowed form (FIG. 4a ) for example a helical shape around the stent 12when in its compressed state. The seal support is expandable to adeployed state (FIG. 4b ), for example, a radially expanded closed orsemi-closed loop form in which the seal support presents the seal 52 inexpanded form around the stent 12.

Referring to FIG. 5, a seal support 54 is illustrated in the form of aneverting portion of the lower region 16 of the stent 12. The sealsupport 54 is movable between a stowed, non-everted configuration and adeployed, everted configuration. In a compressed form constrained by asheath 56 (FIG. 5a ), the lower portion of the stent including the sealsupport 54 is generally tubular (non-evened). As the sheath 56 isprogressively removed axially (FIG. 5b ), the seal support 56 isunsheathed. Unconstrained, the seal support 56 everts to its deployedstate in which the seal is presented and/or biased radially outwardlyfrom the stent body. Further unsheathing of the stent 12 or the lowerportion 16 (FIG. 5c ) permits the stent 12 to expand to its expandedstate. The everted seal support 54 urges the seal into tight sealingcontact with the surrounding tissue/lumen. The seal may be carried onthe inners surface of the stent when compressed, and presented in anoutward direction when everted.

FIG. 6 illustrates a seal support that is similar to both FIGS. 2 and 5.The seal support 58 comprises flexible cantilever elements at the lowerportion 16 of the stent 12, similar to those of FIG. 2 The seal support58 also resembles the everted state of the seal support 56 of FIG. 5. Inthe example of FIG. 6, the cantilever elements do not move between aneverted and non-everted state. In the stowed state, the cantileverelements are generally flat against or within the structure of the stent12 (similar to FIG. 2).

FIG. 7 illustrates a seal in the form of a rollable bead or cuff 60. Therollable cuff 60 may be self-biased or it may be supported by a sealsupport frame that tends to roll the cuff 60. In a stowed state (FIG. 7b), the cuff is unrolled to define a generally flat tubular form. Thecuff may be constrained in the stowed state by a constraining sheath 62of a delivery device. When unsheathed, the cuff 60 is free to move toits deployed state (FIG. 7a ) in which the cuff 60 rolls up to define acuff or bead shape. Such a seal provides a compliant bead of material tofill any gap between the stent 12 and the surrounding tissue/lumen.

FIG. 8 illustrates a seal 74 in the form of foam, or sponge or fibrousporous material. Such material is compressible when dry, because air iseasily expelled from the pores and/or interstices of material whencompressed. The seal 74 may therefore adopt a compressed state withoutincreasing the bulk of the stent-valve 10 significantly. Once implanted,blood may penetrate and fill the pores and/or interstices of the sealmaterial. The blood may become trapped in the pores and/or interstices,thereby creating a barrier to blood flow through the material. The bloodmay also cause distension of the seal material to further expand theseal outwardly and fill any gaps of voids around the stent-valve 10.

FIG. 9 illustrates a seal in the form of a flexible skirt 80. The skirt80 depends, for example, from the junction between the upper crown 18and the lower portion 16 of the stent 16, to at least partly overlap thelower portion 16. A first (e.g. upper) portion 82 of the skirt 80 iscoupled to the stent 12, to hold the skirt 80 captive. For example, thefirst portion 82 may be sutured to the stent 12. A second (e.g.depending) portion 84 of the skirt 80 is generally unconstrained, and isfree to float relative to the stent 12.

As illustrated in FIG. 9b (and explained above in relation to FIG. 1),the implantation procedure for the stent-valve 10 may involve displacingthe stent-valve in the direction of arrow 24 to seat the upper crown 18against native valve leaflets. The friction between the floating secondportion 84 of the skirt 80, and the surrounding tissue/lumen may causethe second portion 84 to bunch or wrinkle axially, thus creating anexcess of material that is able to seal any gap between the stent-valve10 and the surrounding tissue/lumen.

FIG. 10 illustrates an alternative seal in the form of a flexible skirt90. In contrast to the skirt of FIG. 9, the skirt 90 projects from theupper crown 18 towards the upper end of the stent 12. As indicated inphantom, under back pressure of blood, or reverse flow of blow aroundthe stent-valve 10, the flexible skirt bears outwardly to seal againstthe surrounding tissue/lumen. The flexible skirt may form a channelshape section such that the back pressure of blood increases the sealingpressure against the surrounding tissue/lumen.

FIG. 11 illustrates an alternative seal in the form of an oversizedflexible skirt 100 that is connected to the stent 12 at one or morepositions to define pleating or bunching. The connections may be bysuturing. The pleating or bunching creates additional compliant materialable to fill vids of gaps between the stent 12 and the surroundingtissue/lumen.

FIG. 12 illustrates an alternative seal in the form of a skirt that isfolded to define a cuff 102. The skirt material is flexible, but thefold creates a radiused bend providing a natural bulge. The bulge biasesthe seal material outwardly in order to fill voids or gaps between thestent 12 and the surrounding tissue/lumen.

FIG. 13 illustrates an alternative seal comprising a plurality offlexible pockets 110. Each pocket may be associated with a respectiveaperture 112 of a lattice structure of the stent, for example, the lowerportion 16 and/or the upper crown 18. The pocket 110 may be defined by aflexible web of material. One wall of the pocket may be define by aportion of the outer skirt. Another wall of the pocket may be defined bya portion of the inner skirt. The pocket may be open on one side facingtowards the outlet end of the stent, and closed in the oppositedirection. In a stowed state, the pocket may collapse or foldsubstantially flat so as not to increase the bulk of the stent-valve.Once deployed, the pocket may open either under the influence of naturalresilience, or under the influence of blood back pressure entering themouth of the pocket. The back pressure causes the pocket to distendoutwardly against surrounding tissue/lumen, and thereby furtherobstructing leakage of blood around the outside of the stent-valve 10.

FIG. 14 illustrates an alternative seal arrangement comprising material120 that swells in response to contact with blood. The swellingcharacteristics increase the bulk of the seal, enabling the seal todistend to fill any gaps between the stent-valve 10 and the surroundingtissue/lumen. Example swellable materials include a hydrogel and/or aliquid swellable polymer, and/or a so called superabsorbent material.The material may, for example, be carried by, or impregnated orotherwise embodied within the outer skirt. For example, the skirt may beof fabric comprising fibers of the swellable material. The material maybe captive within a containing chamber, for example a flexible and/ordistensible pouch or cuff. The combination of inner and outer skirts,with one comprising swellable material, can provide an especiallyeffective seal arrangement. Further background information of use of,for example, a hydrogel for stent-valves may be found in US 2005/137688.

The seal of FIG. 14 is also illustrated in other embodiments of FIGS. 18and 19. The swellable material is denoted by numeral 44, the containingchamber 42, together defining the paravalve seal 40 carried by, orcomprised within, the outer skirt 32.

FIG. 15 illustrates an alternative seal arrangement in which a sealant122 is dispensed from the delivery catheter 124 (or from a furtherdelivery catheter inserted after implantation), in order to seal aroundthe periphery of the stent valve 10. For example, the sealant isdispensed on the outflow side of the stent-valve to seal any gapsbetween the upper crown and the native leaflets.

FIG. 16 illustrates an alternative seal arrangement comprising material124 that provides hemostatic and/or coagulant effects in response tocontact with blood. The material 124 may, for example, be carried by, orimpregnated or otherwise embodied within the outer skirt. The materialmay be captive within a containing chamber, for example a flexibleand/or distensible pouch or cuff. The combination of inner and outerskirts, with one comprising such material, can provide an especiallyeffective seal arrangement.

FIG. 17 illustrates an alternative seal arrangement comprising material126 that elutes calcium locally. The calcium may deposit directly orindirectly against the surrounding tissue/lumen such that any gaps canbe occluded. The material 126 may, for example, be carried by, orimpregnated or otherwise embodied within the outer skirt The materialmay be captive within a containing chamber, for example a flexibleand/or distensible pouch or cuff. The combination of inner and outerskirts, with one comprising such material, can provide an especiallyeffective seal arrangement.

Although the seal arrangements have been described as alternatives, itis envisaged that any two or more of the seal arrangements may becombined for synergistic effect.

Any and all references to publications or other documents, including butnot limited to, patents, patent applications, articles, webpages, books,etc., presented in the present application, are herein incorporated byreference in their entirety.

Although a few variations of the disclosed subject matter have beendescribed in detail above, other modifications are possible. Forexample, any logic flow depicted in the accompanying figures and/ordescribed herein does not require the particular order shown, orsequential order, to achieve desirable results. Other implementationsmay be within the scope of at least some of the following exemplaryclaims.

Example embodiments of the devices, systems and methods have beendescribed herein. As noted elsewhere, these embodiments have beendescribed for illustrative purposes only and are not limiting. Otherembodiments are possible and are covered by the disclosure, which willbe apparent from the teachings contained herein. Thus, the breadth andscope of the disclosure should not be limited by any of theabove-described embodiments but should be defined only in accordancewith claims supported by the present disclosure and their equivalents.Moreover, embodiments of the subject disclosure may include methods,systems and devices which may further include any and all elements fromany other disclosed methods, systems, and devices, including any and allelements corresponding to stent-valves, and/or seals for stent-valves.In other words, elements from one or another disclosed embodiments maybe interchangeable with elements from other disclosed embodiments. Inaddition, one or more features/elements of disclosed embodiments may beremoved and still result in patentable subject matter (and thus,resulting in yet more embodiments of the subject disclosure).

What is claimed is:
 1. A stent-valve for transcatheter implantation toreplace a cardiac valve, the stent valve being compressible to acompressed state for delivery, and expandable to an operative state forimplantation, the stent-valve comprising a stent, a plurality ofleaflets for defining a prosthetic valve, an inner skirt, an outerskirt, and a paravalve seal for sealing against surrounding tissue, theparavalve seal comprising material that swells in response to contactwith blood.
 2. The stent-valve of claim 1, wherein at least one of theskirts comprises the swellable material.
 3. The stent-valve of claim 1,wherein the stent comprises at least one of: a lower tubular portion; anupper crown portion; a plurality of upstanding commissural supports; aplurality of stabilization arches.
 4. The stent-valve of claim 3,wherein the stent comprises the lower tubular portion, the upper crownportion, the plurality of upstanding commissural supports, and theplurality of stabilization arches.
 5. The stent-valve of claim 4,wherein the lower tubular portion communicates with the upper crown andthe commissural supports, wherein the commissural supports up-standrelative to the upper crown portion, and wherein the stabilizationarches communicate with the commissural supports.
 6. The stent-valve ofclaim 4, wherein the swellable material is positioned between and spacedfrom respective extremities of both a free edge of the upper crown, anda free edge of the lower tubular portion.
 7. The stent-valve of claim 4,wherein the lower tubular portion is configured for deployment after atleast partial deployment of the upper crown portion, the commissuralsupports and the stabilization arches.
 8. The stent-valve of claim 1,wherein the outer skirt comprises fabric comprising fibers of theswellable material.
 9. The stent-valve of claim 1, wherein the swellablematerial is captive within a containing chamber, the containing chambercarried by the outer skirt.
 10. A stent-valve for transcatheterimplantation to replace a cardiac valve, the stent valve beingcompressible to a compressed state for delivery, and expandable to anoperative state for implantation, the stent-valve comprising a stent, aplurality of leaflets for defining a prosthetic valve, and a paravalveseal for sealing against surrounding tissue, the paravalve sealcomprising material that swells in response to contact with blood, theparavalve seal being positioned towards one extremity of the stent, andspaced from said one extremity.
 11. The stent-valve of claim 10, whereinsaid one extremity of the stent comprises a zig-zag edge, the zig-zagedge including first apexes alternating with second apexes, wherein theparavalve seal is positioned such that it does not extend in the regionbetween the apexes.